Site visit. In most cases a site visit is needed. Only in rare instances may an investigation take place without the consultant being on site. In this case, exchange of photos is a necessity. Ask the consultant what he/she will be viewing. It is most instructive to see the equipment moving as it does in production and also to view the sanitation crew from dry pickup through cleaning. If production is still running, viewing pre-operation setup, operations, and shift changes are instrumental to piecing together root causes.
Swabs. Microbiological sampling of the equipment and site will be needed to determine the harborage point. Ask the consultant if he/she will be taking the samples or if the company’s QA team can or should assist. It is always helpful to have a few people handy to label swabs, fill out lab request sheets, note swab descriptions, and, if permissible, take photos. A photo is truly worth a thousand words and comes in handy during team debriefing at the conclusion of each day. As a company outsider, it is often difficult to name equipment in the same terms as the company. Even similar equipment is named something different by each company. Some slicers are named, aptly, “slicer” while others term their slicer a “flux capacitor.” Also, the name of the room can be confusing for someone who is new to the area. Yet these are important aspects to identify swab locations, especially when a swab is positive.
Maintenance. It is always helpful to have someone from maintenance available to remove side panels, motor housings, chain guards, and open electrical panels. Discuss how equipment runs and the maintenance events that may have impacted bacterial harborages. Rare is the case that there is no need to see inside equipment so having those areas accessible for swabbing is an important investigative tool. These sites are the areas where soils can accumulate and bacteria will thrive.
Lab. If the lab is onsite, have available the method of testing, lab employee training, and lab audit documentation. If a third-party lab is used, show the consultant the ISO 17025 certification and show that the methods used for the swabs taken on site are contained within the ISO certification. This is a good double check for the company. Make sure the lab understands there will be an increased sample volume and discuss with the consultant the courier pick-up times so swabbing can be completed each day in time for sample pickup or shipment.
Dry runs. Once a harborage site has been identified through testing and renovations enacted, conducting dry runs to validate that the activities have been successful are a component of the harborage site process. A minimum of three dry runs will be necessary to verify effectiveness of the removal process. Keeping in mind that after each dry run, sponges are taken as a scientific verification, the test times need to be considered. The dry run process alone can add a week to the investigative process.
Time. It takes a number of days to get familiar with the processing environment and equipment. Often swabbing is not completed within the first day and there may need to be multiple swabbing events if the first round was unsuccessful in uncovering the harborage site(s). If samples are shipped then there is usually a day delay and testing can take up to 48 hours additional to a negative result. Determine beforehand if testing will stop at presumptive or if the testing will be confirmed, which may take an additional 5-7 days.
Expected outcome. Discovery of the root cause and any secondary sites is expected. Oversee the harborage site(s) removal and verification that the production environment is free of the pathogen.
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